The present invention relates to devices for sealing puncture wounds in blood vessels caused by any one of a number of medical procedures, and to methods for sealing such puncture wounds using the device.
In certain medical procedures, such as cardiac catheterization, dilation and counterpulsation, a catheter or other device is inserted in an artery, most commonly by percutaneous methods, and then fed through the arterial tree to the site where needed, frequently, the region of the heart. The site usually selected for insertion is the groin, because the femoral artery in that region is relatively easy to locate.
These procedures are normally initiated by the insertion of an angiographic needle, followed by passing a guide wire through that needle into the artery. The needle is then removed, leaving the guide wire in place. Next, a sheath/dilator set is passed over the guide wire into the artery in order to enlarge the opening sufficiently to permit entry of the catheter or other device. The dilator is then removed leaving the sheath or guide cannula in place. The catheter or other device can then be inserted through the cannula with full confidence that when it emerges from the distal end it will be within the lumen of the artery.
After a procedure, for example, counterpulsation, has been completed, the sheath must be removed and the wound closed. Often, this can be accomplished simply by the application of digital pressure, generally augmented by the use of a conventional pressure dressing, until hemostasis is achieved. Customarily, pressure must be applied for at least one-half hour, and frequently for much longer than that. While pressure dressings often suffice, it is not uncommon for addition devices, such as sand bags, to be needed. In addition, during this period the patient must be immobilized, lest movement interfere with the closing process. Because of the pressure required, the time during which it must be applied and the need for immobilization, the procedure is painful and uncomfortable. It also requires the prolonged personal attention of a healthcare professional. Finally, wound closures accomplished in this matter are prone to reopen unexpectedly long after closure appears to have been completed. Patients are therefore often required to maintain bed rest, oftentimes in the hospital, for 24 hours or longer.
Since sealing can be such a problem, cardiologists tend to use the smallest caliber catheters when performing catheterization procedures. Larger caliber catheters, however, are far preferable. An improved sealing procedure whereby larger catheters can be used without increasing the sealing difficulties would greatly facilitate cardiac catheterization.